Pharmacokinetics of GH001 in Healthy Volunteers

NCT05163691 | Completed Phase 1

• 2 other identifiers: GH001-HV-1032021-000241-40
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective of this study is to investigate the serum pharmacokinetics of 5-MeO-DMT and its metabolite, bufotenine in healthy volunteers in a double-blind, placebo-controlled, randomized study design with single, inhaled doses of GH001 and in an open-label, non-randomized study design with intra-subject dose-escalation of GH001. As a secondary objective, the safety and tolerability of GH001, the mental health and well-being of the subjects after GH001 dosing(s), the pharmacodynamic profile of GH001 as evaluated by its psychoactive effects, and cognitive measures are also assessed.

Conditions

Healthy Volunteers

Keywords

5-MeO-DMT; 5-methoxy-N,N-dimethyltryptamine; 5-methoxy-dimethyltryptamine; Healthy Volunteers; Pharmacokinetics

Outcome Measures

Primary Outcomes (1)

• The pharmacokinetic (PK) parameters derived from laboratory assay results of the systemic levels of 5-MeO-DMT and bufotenine

  For PK analyses, blood samples will be collected before and up to 4 hours after the administration of GH001 to determine 5-MeO-DMT and bufotenine serum concentrations.

  up to 4 hours

Secondary Outcomes (18)

• Safety: Adverse Event (AE) reporting

  Up to 30 days

• Safety: Frequency of clinically significant changes from baseline in electrocardiogram (ECG) recording

  Up to 7 days

• Safety: Frequency of clinically significant changes from baseline in vital signs measurement

  Up to 7 days

• Safety: Frequency of clinically significant changes from baseline in safety laboratory tests of blood and urine

  Up to 7 days

• Safety: Frequency of clinically significant changes from baseline in Peak Flow Respirometry

  1 hour after dosing

Study Arms (5)

Group A - 6 mg single-dose

EXPERIMENTAL

A single, inhaled dose of GH001 6 mg or placebo (randomized as 8 active and 2 placebo subjects)

Drug: 5 Methoxy N,N Dimethyltryptamine; Drug: Placebo

Group B - 12 mg single-dose

EXPERIMENTAL

A single, inhaled dose of GH001 12 mg or placebo (randomized as 8 active and 2 placebo subjects)

Drug: 5 Methoxy N,N Dimethyltryptamine; Drug: Placebo

Group C - 18 mg single-dose

EXPERIMENTAL

A single, inhaled dose of GH001 18 mg or placebo (randomized as 8 active and 2 placebo subjects)

Drug: 5 Methoxy N,N Dimethyltryptamine; Drug: Placebo

Group D - Individualized Dosing Regimen, 1-hour interval

EXPERIMENTAL

Administration of up to 3 inhaled doses of GH001 within a single day (6 mg, followed by 12 mg, followed by 18 mg) with a 1-hour dose interval (8 subjects)

Drug: 5 Methoxy N,N Dimethyltryptamine

Group E - Individualized Dosing Regimen, 2-hour interval

EXPERIMENTAL

Administration of up to 3 inhaled doses of GH001 within a single day (6 mg, followed by 12 mg, followed by 18 mg) with a 2-hour dose interval (8 subjects)

Drug: 5 Methoxy N,N Dimethyltryptamine

Interventions

5 Methoxy N,N Dimethyltryptamine DRUG

GH001 administered via inhalation

Also known as: GH001, 5-MeO-DMT

Group A - 6 mg single-dose; Group B - 12 mg single-dose; Group C - 18 mg single-dose; Group D - Individualized Dosing Regimen, 1-hour interval; Group E - Individualized Dosing Regimen, 2-hour interval

Placebo DRUG

GH001 Placebo administered via inhalation

Also known as: GH001 Placebo

Group A - 6 mg single-dose; Group B - 12 mg single-dose; Group C - 18 mg single-dose

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Subject has a body mass index (BMI) in the range of 18.5 and 35.0 kg/m2 (inclusive);
• Subject is in good physical health in the opinion of the principal investigator (PI);
• Subject is in good mental health in the opinion of the PI and clinical psychologist;

You may not qualify if:

• Has known allergies or hypersensitivity or any other contraindication to 5-MeO-DMT;
• Has received any investigational medication within the last 4 weeks;
• Has a medical condition, which renders the subject unsuitable for the study.

Sponsors & Collaborators

• GH Research Ireland Limited: lead

Study Sites (1)

GH Research Clinical Trial Site

Groningen, Netherlands

Location

Related Links

• GH Research Company Website

MeSH Terms

Interventions

Methoxydimethyltryptamines

Intervention Hierarchy (Ancestors)

N,N-Dimethyltryptamine; Tryptamines; Biogenic Monoamines; Biogenic Amines; Amines; Organic Chemicals; Bufotenin; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Serotonin

Study Officials

• GH Research Clinical Team

  GH Research Ireland Limited

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This study will include separate single- and multiple-dose parts. Single-dose Part: A double-blind, placebo-controlled, randomized, parallel-group design with single, inhaled doses of GH001 in 3 groups of 10 subjects (randomized as 8 active and 2 placebo subjects per group): * Group A: single inhaled dose of 6 mg GH001 * Group B: single inhaled dose of 12 mg GH001 * Group C: single inhaled dose of 18 mg GH001 Multiple-Dose Part: An open-label, non-randomized administration of up to 3 inhaled doses of GH001 within a single day (6 mg, followed by 12 mg, followed by 18 mg) with two different dose intervals (8 subjects per group): * Group D: 1-hour interval * Group E: 2-hour interval

Study Record Dates

• First Submitted: November 18, 2021
• First Posted: December 20, 2021
• Study Start: June 21, 2021
• Primary Completion: October 23, 2021
• Study Completion: November 22, 2021
• Last Updated: December 20, 2021

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)